sunlenca

Generic: lenacapavir sodium

Labeler: gilead sciences, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sunlenca
Generic Name lenacapavir sodium
Labeler gilead sciences, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lenacapavir sodium 300 mg/1

Manufacturer
Gilead Sciences, Inc.

Identifiers & Regulatory

Product NDC 61958-3001
Product ID 61958-3001_1181413a-1da0-463f-bd33-a2681d2fcd9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215974
Listing Expiration 2027-12-31
Marketing Start 2022-12-22

Pharmacologic Class

Classes
breast cancer resistance protein inhibitors [moa] cytochrome p450 3a inhibitors [moa] hiv capsid inhibitors [moa] human immunodeficiency virus 1 capsid inhibitor [epc] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 619583001
Hyphenated Format 61958-3001

Supplemental Identifiers

RxCUI
2625890 2625896 2625897 2625898 2625899 2625900 2625904 2625909 2625911 2625912
UNII
BDT58WJ9WE

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sunlenca (source: ndc)
Generic Name lenacapavir sodium (source: ndc)
Application Number NDA215974 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (61958-3001-1) / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 POUCH in 1 CARTON (61958-3001-2) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-3)
source: ndc

Packages (3)

61958-3001-1 1 POUCH in 1 CARTON (61958-3001-1) / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK 61958-3001-2 1 POUCH in 1 CARTON (61958-3001-2) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACK 61958-3001-3 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-3)

Ingredients (1)

lenacapavir sodium (300 mg/1)

Linked Drug Pages (1)

Sunlenca ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1181413a-1da0-463f-bd33-a2681d2fcd9b", "openfda": {"unii": ["BDT58WJ9WE"], "rxcui": ["2625890", "2625896", "2625897", "2625898", "2625899", "2625900", "2625904", "2625909", "2625911", "2625912"], "spl_set_id": ["e5652804-29c4-40d7-aeb2-0142ed2a7b5b"], "manufacturer_name": ["Gilead Sciences, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (61958-3001-1)  / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "61958-3001-1", "marketing_start_date": "20221222"}, {"sample": false, "description": "1 POUCH in 1 CARTON (61958-3001-2)  / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "61958-3001-2", "marketing_start_date": "20221222"}, {"sample": false, "description": "4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-3)", "package_ndc": "61958-3001-3", "marketing_start_date": "20241113"}], "brand_name": "Sunlenca", "product_id": "61958-3001_1181413a-1da0-463f-bd33-a2681d2fcd9b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Breast Cancer Resistance Protein Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "HIV Capsid Inhibitors [MoA]", "Human Immunodeficiency Virus 1 Capsid Inhibitor [EPC]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "61958-3001", "generic_name": "LENACAPAVIR SODIUM", "labeler_name": "Gilead Sciences, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sunlenca", "active_ingredients": [{"name": "LENACAPAVIR SODIUM", "strength": "300 mg/1"}], "application_number": "NDA215974", "marketing_category": "NDA", "marketing_start_date": "20221222", "listing_expiration_date": "20271231"}